Item Brochure

Technical File for the Vein-Eye® Carry medical device
Table of contents
Page(s)
General information concerning the structure and use
2, 3
Safety, testing, certification
Tariff Commodity Code, Country of Origin, Input power
4
5
Explanation of NIR wavelengths
6
Photographs of components
7, 8, 9, 10
Photographs and list of applicable standards
10
List of components
12
Packaging specification
12
Sub- assembly drawings, circuitry and QA
(e.g., QC specs, in-process and end-controls, end-release etc.)
13
Labelling, accompanying documents, package insert
14
Description about the creation of a Lot or Charge No.
14
Instructions for use (e.g., EN 1041)
14
Intended / clinical use
14
Customer Service
14
Product verification
15
Testing data and reports, functionality studies,
wet lab or bench top testing
15
EMC testing and certificates
15
Compatibility studies (connection to other devices)
15
Risk management documentation (EN ISO 14971)
15
Hazard Analysis
15
Power and battery information
16
Product validation
16
Validation of the packaging/ageing studies
17
Process validation (e.g., sterilization,
manufacturing, production)
17
System parameters
18
FDA Registration
19
Intertek test report
20
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Summary of content (20 pages)